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Not yet recruiting NCT07750756

Hyaluronic Acid vs I-PRF With Microneedling in Enhancing Peri-implant Soft Tissue

Phase II / Phase III Interventional Peri-implant Mucosa Thickness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hyaluronic Acid (HA), Platelet rich fibrin.
Who it may be relevant to
Registry conditions: Peri-implant Mucosa Thickness. Basic parameters: 21 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Hyaluronic Acid Versus I-PRF Combined With Microneedling for Peri Implant Soft Tissue Enhancement: A Randomized Controlled Clinical Trial

Overview

This study aims to compare the use of microneedling alone versus with hyaluronic acid or i-PRF in conjunction with microneedling in peri-implant mucosa in the esthetic zone to test the superior increase in gingival thickness.

Detailed description

Despite the rising demand for esthetics and the prevailing use of dental implants in the recent era, the soft tissue remains a dilemma that affects patients' satisfaction and the implants' longevity in the oral environment, especially in the esthetic region of the maxilla. Various studies have been done to test the effectiveness of microneedling, hyaluronic acid, and i-PRF as alternative non-invasive or minimally invasive methods targeting tissue enhancement in the gingiva, and have proven that they have notable and desirable results. However, there is a lack in the literature regarding the use of these previously mentioned treatment options with regard to peri-implant soft tissue, and which of the delivered solutions offers superior results with reference to peri-implant mucosa in conjunction with microneedling.

Interventions

  • Drug Hyaluronic Acid (HA)
    Hyaluronic acid (HA) is a genuine linear glycosaminoglycan that is present within the extracellular matrix of connective, epithelial, and neural tissues.
  • Biological Platelet rich fibrin
    Injectable PRF (i-PRF) is a notable method in enhancing soft tissue phenotypes, relying on its injectable form that can be well delivered to targeted areas to ensure proper distribution of growth factors and cytokines.

Primary outcome measures

  • Peri-implant gingival thickness [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Patients with delayed implants placed in the maxillary esthetic region in correct positioning and angulation
  • Patients with peri-implant gingival thickness ≤ 1 mm
  • Patients with healthy gingiva and who can maintain good oral hygiene around implants

Exclusion criteria

  • Marginal bone loss ≤ 2 mm
  • Patients with peri-implantitis or periodontitis
  • Patients with systemic conditions or diseases impairing healing or soft tissue metabolism
  • Pregnant or lactating females
  • Patients taking medications affecting the gingiva

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07750756 · 1673

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗